New Delhi:The World Health Organization (WHO) has told the central government that the United Nations (UN) agency’s work with India would be “hampered" and drug companies driven away if the government goes ahead with stringent draft rules for compensation in case of death or injury from clinical trials.

In a letter to health secretary Preeti Sudan on 19 June, WHO deputy director general Soumya Swaminathan said India should “reconsider" the compensation clause because an approval to the rules in the current form would affect the conduct of international and nationally-sponsored clinical trials in India.

The Union health ministry’s proposals made in February included a provision for the deceased party in a trial to be paid 60% of the compensation within 15 days if the patient dies or suffers a permanent disability in the course of a trial.

Additionally, if it is proved after an investigation that the death or disability did not occur because of the trial, the interim compensation will not be returned.

According to the proposed rules, if the injury is related to a clinical trial in addition to the medical management, the participant would also be provided financial compensation by the sponsor as determined by a proposed ethics committee (EC). The financial compensation would be over and above any expenses incurred in medical management of the subject.

The ethics committee is a proposed government body that will ensure medical experiments and research on humans are carried out in an ethical manner and provide feedback on the ethical appropriateness of the trial. It will consist of seven members, including experts from medical science, non-medical stream, scientific and non-scientific members, a layman and a woman member, said an official at the Central Drugs Standard Control Organization, who requested anonymity.

Stating that many sponsors are likely to consider this “unacceptable", Swaminathan in her letter said it is not the usual practice internationally for ethics committees to make such decisions and that it would place an unfair burden on them, given their lack of expertise.

“I fear that if the rules are finalized as they currently stand, there is a possibility that sponsors will not conduct clinical trials in India and go elsewhere," she said. “It will also hamper WHO’s work with India where we consider that it is a public health priority to conduct clinical trials on a particular condition in India, WHO ourselves may not wish to act as sponsor and other partners may be similarly discouraged." Mint has reviewed a copy of the letter.

“I asked WHO colleagues to review this," she said. “Our major concern is the reaction sponsors are likely to have to the scenario, whereby the ethics committee determines a death or permanent disability is related to the product, but the sponsor disagrees. In this case 60% of the fee has to be paid upfront before the central licensing authority goes through its expert review process to adjudicate and this is not reimbursable regardless of the decision of the further steps of the process."

Concerns have also emerged in the government over this clause, with the Indian Council of Medical Research (ICMR) raising objections. The director general of ICMR, Balram Bhargava, has written to the heath ministry stating that some of the clauses may be detrimental to the future of clinical trials in India. “At present most ethics committees in India are not appropriately trained with variations in quality and efficiency to review to deal with the issue of compensation," he said. “It is therefore important that the ministry’s expert committee on serious adverse effects review the causality analysis done by the EC and can agree or modify and provide its final opinion." Accordingly, he has suggested revision of the clauses so that they are “realistic".

Following these suggestions, the ministry has already started deliberations. “The ministry held a meeting with the stakeholders, comprising pharma companies and pharma lobby groups," an official in the health ministry said, requesting anonymity. “The draft rules will be modified once we have clarity from all affected parties."